Treatment of Apathy in Alzheimer's Disease With Modafinil - Full Text View

Purpose

This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).

Condition	Intervention	Phase
Apathy Alzheimer's Disease	Drug: Modafinil Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Apathy in Alzheimer's Disease With Modafinil

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Modafinil Armodafinil

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Further study details as provided by Brown University:

Primary Outcome Measures:

Apathy [ Time Frame: at baseline ] [ Designated as safety issue: No ]
The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.
Apathy [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.

Secondary Outcome Measures:

Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: at baseline ] [ Designated as safety issue: No ]
Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
The Direct Assessment of Functional Status Scale [ Time Frame: at baseline ] [ Designated as safety issue: No ]
A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Zarit Burden Inventory [ Time Frame: at baseline ] [ Designated as safety issue: No ]
Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.
Lawton Brody Activities of Daily Living Questionnaire [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.
The Direct Assessment of Functional Status Scale [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.
Zarit Burden Inventory [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]
Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.


Enrollment:	22
Study Start Date:	July 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
Placebo Comparator: Cholinesterase inhibitor only	Drug: Placebo 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
Experimental: Cholinesterase Plus Modafinil	Drug: Modafinil 100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks Other Name: Provigil

Eligibility


Ages Eligible for Study:	65 Years to 95 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

diagnosis of mild to moderate stage Probable Alzheimer's disease
on a stable dose of a cholinesterase inhibitor medication for at least 30 days
clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

diagnosis of Major Depression
focal brain lesion on neuroimaging
history of significant substance abuse
history of significant head trauma with loss if consciousness >10 minutes

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172145

Locations


United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Brown University

National Institute of Mental Health (NIMH)

Cephalon

Investigators


Principal Investigator:	Laura L Frakey, Ph.D.	Memorial Hospital of Rhode Island

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frakey LL, Salloway S, Buelow M, Malloy P. A randomized, double-blind, placebo-controlled trial of modafinil for the treatment of apathy in individuals with mild-to-moderate Alzheimer's disease. J Clin Psychiatry. 2012 Jun;73(6):796-801. doi: 10.4088/JCP.10m06708. Epub 2012 May 15.


Responsible Party:	Laura L. Frakey, Brown University
ClinicalTrials.gov Identifier:	NCT01172145 History of Changes
Other Study ID Numbers:	1F32MH075583-01
Study First Received:	July 28, 2010
Results First Received:	August 4, 2010
Last Updated:	February 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Brown University:


apathy Alzheimer's disease activities of daily living performance caregiver burden

Additional relevant MeSH terms:


Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders	Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016